Variable Diameter Surgical Drains and Sheaths

ABSTRACT

Surgical drains and methods for using the same for draining a body cavity are provided. Aspects of the surgical drains of the invention include an elongated structure having a proximal end and a distal end and a lumen configured to drain a substance from the body cavity. The distal end is configured to be placed in a body cavity and change in diameter when present in the body cavity from a first diameter to a second diameter that is smaller than the first diameter, where the change in diameter is mediated by a diameter-varying element. Aspects of the invention further include sheaths configured to be disposed around surgical drains, such as surgical drains of the invention, and methods of using the surgical drains and sheaths. The devices and methods of the invention find use in a variety of applications.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/759,826 filed Feb. 5, 2013, now U.S. Pat. No. 10,307,574, which is acontinuation of U.S. application Ser. No. 12/485,651 filed Jun. 16,2009, now U.S. Pat. No. 8,403,913, which application claims prioritypursuant to 35 U.S.C. § 119(e) to the filing date of U.S. ProvisionalPatent Application Ser. No. 61/132,119 filed Jun. 16, 2008; thedisclosures of which applications are herein incorporated by reference.

INTRODUCTION

The nature of indwelling surgical drains, catheters, tubes or cannulascauses significant discomfort for the awake patient or animal. Thediscomfort is due to the contact of the drain or tube with internalstructures, such as nerves, mucosal membranes, pleural, pericardial orperitoneal linings, skin or other tissues in contact with the draintract while the drain is indwelling. For example, a chest tube left inthe pleural cavity after cardiac or thoracic surgery is in contact withthe visceral and parietal surfaces of the lung and chest wall, which areexquisitely sensitive. The tube usually also traverses the intercostalspace, which is also quite sensitive.

A drain or chest tube is necessary after a surgical procedure in orderto evacuate the air and body fluids and maintain the expansion of thelung required for respiration. The pleural space is normally maintainedat a pressure slightly negative relative to atmospheric pressure by thebody. While a chest tube or drain is in place, a slightly negativepressure can be maintained by suction applied via the drain. Maintenanceof the negative pressure is one of the functions of a chest drain tube,in addition to the evacuation of air, body fluids, blood, clots andsemi-solid and solid material.

FIG. 1 shows an example of a typical position of a thoracic chest tubedrain 101 placed in the thoracic cavity of a human to evacuate air andbody fluid. Also shown are fenestrations 102, which are holes within thechest tube to allow for the ingress of fluid and air into the centrallumen of the tube. Drainage of the chest cavity using this type of chesttube has been employed for at least a century, with tubes constructed ofvarious materials such as rubber, plastic, polymers, silicone, etc. Whenthe chest tube is withdrawn, the hardness of the drain 101 and the sharpedges of the fenestrations 102 cause pain via contact with the tissuesin multiple places including at the lining around the lungs (thevisceral pleura), the lung lining at the chest wall (the parietalpleura), the intercostal space, adjacent nerves, and the skin. Theindwelling nature of the drain and the need for rapid withdrawal of thechest tube to prevent air from entering via the tract of the draincauses significant pain, requiring intravenous or other narcotic painrelief.

With the aid of pain medications, patients can adjust to the discomfortof an indwelling tube for the several days the drains are needed, butthen it is necessary to remove the drain relatively quickly so that noair is allowed into the thoracic cavity during removal. The relativelyrapid withdrawal of chest drains or other functioning tubes from thethoracic cavity or other body cavities or organs tends to be arelatively painful experience for the patient. The pain is not sosevere, however, to warrant the risks and expense of general anesthesia,nor is it practical to anesthetize via external injection the entirelength of the tissue tract in contact with the tube to be removed.

Therefore, there is a need for improved surgical drains and methods forusing surgical drains. There is a need for surgical drains which canprovide a large area for effective therapeutic drainage of a body cavityduring use, with the ability to significantly decrease the diameter ofthe surgical drain prior to removal of the drain from the body cavity.It would be a significant improvement in the patient's post-proceduralexperience to be able to decrease the pain experienced by a patientwhile the drain is indwelling, and during removal of the surgical drain.

SUMMARY

Surgical drains and methods for using the same for draining a bodycavity are provided. Aspects of the surgical drains of the inventioninclude an elongated structure having a proximal end and a distal endand a lumen configured to drain a substance from the body cavity. Thedistal end is configured to be placed in a body cavity and change indiameter when present in the body cavity from a first diameter to asecond diameter that is smaller than the first diameter, where thechange in diameter is mediated by a diameter-varying element. Aspects ofthe invention further include sheaths configured to be disposed aroundsurgical drains, such as surgical drains of the invention, and methodsof using the surgical drains and sheaths. The devices and methods of theinvention find use in a variety of applications.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 provides a view of a prior art chest tube placed in a thoraciccavity.

FIGS. 2A and 2B provide views of surgical drains, according toembodiments of the invention.

FIGS. 3A and 3B provide a view of an embodiment of a surgical drain witha diameter-varying element, according to an embodiment of the invention.

FIG. 4 provides a view of another embodiment of a surgical drain with adiameter-varying element in the form of a wire, according to anembodiment of the invention.

FIGS. 5A and 5B provide a view of an embodiment of a surgical drain witha diameter-varying element in the form of a wire, according to anembodiment of the invention.

FIGS. 6A and 6B provide views of a surgical drain with adiameter-varying element in the form of a balloon, in accordance with anembodiment of the invention.

FIGS. 7A to 7C provide additional views of surgical drains withdiameter-varying elements in the form of one or more balloons, accordingto an embodiment of the invention.

FIGS. 8A and 8B provide a detailed view of another embodiment of asurgical drain with diameter-varying elements in the form of one or moreballoons, according to an embodiment of the invention.

FIGS. 9A and 9B provide a view of an embodiment of a surgical drain witha diameter-varying element is in the core of the elongated structure,according to an embodiment of the invention.

FIGS. 10A and 10B provide additional views of surgical drains whereinthe diameter-varying element is in the core of the elongated structure.

FIG. 11 provides a view of an embodiment of the surgical drain withbranches, according to an embodiment of the invention.

FIG. 12 provides a view of another embodiment of a surgical drain withbranches, showing a lateral view of the thoracic cavity, according to anembodiment of the invention.

FIG. 13 provides a view of the embodiment of the surgical drain as inFIG. 12, showing an anterior to posterior view of the thoracic cavity,according to an embodiment of the invention.

FIGS. 14A and 14B provide views of another embodiment of a surgicaldrain with branches, showing an anterior to posterior view of thethoracic cavity before and after removal of the diameter-varyingelement, according to an embodiment of the invention.

FIG. 15 provides a view of the proximal portion of the surgical drain,which exits the body cavity and is fixed to the skin, according to anembodiment of the invention.

FIGS. 16A and 16B provide views of a sheath for a surgical drain in bothan expanded and a collapsed configuration, according to an embodiment ofthe invention.

FIGS. 17A and 17B provide additional views of a sheath for a surgicaldrain in both an expanded and a collapsed configuration, according to anembodiment of the invention.

FIGS. 18A and 18B provide detailed views of a sheath for a surgicaldrain, according to an embodiment of the invention.

FIG. 19 provides a view of the sheath in an expanded configurationplaced over a surgical drain, according to an embodiment of theinvention.

FIG. 20 provides another view of the sheath in an expanded configurationplaced over a surgical drain, as the surgical drain is being withdrawn,according to an embodiment of the invention.

FIG. 21 provides a view of a sheath for a surgical drain in a collapsedconfiguration, as the surgical drain is being withdrawn, according to anembodiment of the invention.

FIG. 22 provides a view of a sheath for a surgical drain, where thesheath is fixed at the proximal end of the drain, according to anembodiment of the invention.

FIG. 23 provides a view of a sheath for a surgical drain, where thesheath is fixed at the proximal end of the drain, as the surgical drainis being withdrawn, according to an embodiment of the invention.

FIG. 24 provides a view of a sheath for a surgical drain, where thesheath is secured to a surgical drain, according to an embodiment of theinvention.

FIG. 25 provides a view of a sheath for a surgical drain, where thesheath is fixed at the distal end of the drain, as the surgical drain isbeing withdrawn, according to an embodiment of the invention.

FIG. 26 provides a view of a sheath for a surgical drain, with anadditional lumen in the wall of the sheath, according to an embodimentof the invention.

FIG. 27 provides a cross-sectional view of the sheath for a surgicaldrain in FIG. 26, according to an embodiment of the invention.

FIG. 28 provides a view of percutaneous insertion of a surgical drain,according to an embodiment of the invention.

FIG. 29 is another embodiment of percutaneous insertion of a surgicaldrain and sheath, according to an embodiment of the invention.

DETAILED DESCRIPTION

Surgical drains and methods for using the same for draining a bodycavity are provided. Aspects of the surgical drains of the inventioninclude an elongated structure having a proximal end and a distal endand a lumen configured to drain a substance from the body cavity. Thedistal end is configured to be placed in a body cavity and change indiameter when present in the body cavity from a first diameter to asecond diameter that is smaller than the first diameter, where thechange in diameter is mediated by a diameter-varying element. Aspects ofthe invention further include sheaths configured to be disposed aroundsurgical drains, such as surgical drains of the invention, and methodsof using the surgical drains and sheaths. The devices and methods of theinvention find use in a variety of applications.

Before the present invention is described in greater detail, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the module of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Certain ranges are presented herein with numerical values being precededby the term “about.” The term “about” is used herein to provide literalsupport for the exact number that it precedes, as well as a number thatis near to or approximately the number that the term precedes. Indetermining whether a number is near to or approximately a specificallyrecited number, the near or approximating unrecited number may be anumber which, in the context in which it is presented, provides thesubstantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

In further describing various aspects of the invention, the surgicaldrains and methods of their use will be described first in greaterdetail, followed by a review of sheaths of the invention and their use.

Surgical Drains

Surgical drains according to certain embodiments of the invention aredevices that are configured to drain a substance from a body cavity. Thesurgical drains are configured to have a larger diameter when present inthe body cavity, and change to a smaller diameter prior to removal fromthe body cavity. The surgical drains can also be used with a sheathconfigured to be disposed around the surgical drain. The subject devicesand methods can be used in percutaneous, minimally invasive surgical,open surgical, or other interventional procedures.

Embodiments of the surgical drains include an elongated structure with aproximal and a distal end, and a lumen configured to drain a substancefrom a body cavity. In the discussion below, both the terms “elongatedstructure”, “surgical drain of the subject invention”, and “subjectsurgical drain” will be used to refer to a surgical drain of the subjectinvention. The elongated structure includes a distal end configured tobe placed in a body cavity, such as a thoracic body cavity, and changein diameter when present in the body cavity from a first diameter to asecond diameter that is smaller than the first diameter. The change indiameter of the distal end of the elongated structure is mediated by adiameter-varying element, described further below. The proximal end ofthe elongated structure is configured to be outside of the body when thedistal end is present in the body cavity.

The elongated structure of the subject invention is an element that candrain a fluid, e.g., a liquid, air, etc, from a body cavity. The bodycavity can include, but is not limited to, any body cavity in need ofdraining, such as a thoracic body cavity, which includes a body cavityin the chest including a pleural body cavity or a pericardial cavity, anabdominal body cavity, a gastrointestinal body cavity, a pelvic bodycavity, a genitourinary body cavity, a cavity in the brain or spinalcord, a cavity in an extremity such as an arm or leg, etc. Further, thebody cavity can be an anatomical or “natural” body cavity, e.g., thepleural space, or peritoneal space, or it can be a surgically-created ordisease-created body cavity, e.g., an abscess cavity. In someembodiments, the body cavity can be a cavity in a solid organ, (e.g.,liver, bone, etc.) In some embodiments, the body cavity can be a holloworgan, or an organ with a lumen, such as a urethra, a ureter, a portionof the intestine, the esophagus, the trachea, a bronchial tube.

In some embodiments, the elongated structure of the subject inventioncan be positioned to reach a body cavity by passing through ananatomical, or natural body tract or orifice. By natural orifice ismeant an opening in the body that is part of a normally presentanatomical structure, which can include but is not limited to the mouth,urethra, anus, vagina, etc. In other embodiments, the elongatedstructure of the subject invention can be positioned to reach a bodycavity by passing through an artificial tissue tract. By artificialtissue tract is meant any tissue tract that is not naturally present inthe body, such as a tract created through a chest wall, an abdominalwall, an extremity, etc. An artificial tissue tract can include a tractthat has been created in the body, such as an iatrogenic tract, i.e., atract created for a surgical procedure, or placement of a surgicaldrain, catheter, tube, etc. An artificial tissue tract can also includea tract that has been created in the body by a disease process, such asinfection, inflammation, or tumor, and can include processes such as adraining abscess cavity, a fistula, a tract created by a tumor or othergrowth, etc.

The dimensions of the elongated structure will vary depending on thephysical location of the surgical drain, and the substance that needs tobe drained. For example, a surgical drain configured to drain a thoracicbody cavity can be longer than a surgical drain configured to drain aurinary bladder. Similarly, an elongated structure configured to drain athoracic body cavity can have a larger diameter than an elongatedstructure configured to drain a urinary bladder. In some instances, thelength of the elongated structure may range from less than 1 cm to morethan 300 cm, such as from 5 cm to 90 cm, and including from 15 cm to 30cm.

The lumen in the elongated structure is configured to drain a substancefrom a body cavity. As such, the lumen can drain substances from anybody cavity as disclosed above. Substances which can be drained,include, but are not limited to, fluids produced by the body includingpleural fluid, pericardial fluid, blood, serous fluid, infected fluid,urine, cerebrospinal fluid, joint fluid, lymph, gastrointestinal fluid,etc. Substances which can be drained can also include fluids which havebeen introduced into the body or body cavity, such as saline, orpharmaceutical agents, etc. As such, the inner diameter of the lumenwill vary depending on the physical location of the surgical drain. Forexample, an elongated structure configured to drain blood that maycontain clots, or infected fluid, or bowel contents, can have a largerdiameter than an elongated structure configured to drain a fluid such asair. In some embodiments, there can be more than one lumen, such as twoor more, or three or more. In some embodiments, the drainage lumen is acentral lumen. In other embodiments, there can be peripheral lumens. Insome embodiments, there can be a central lumen and peripheral lumensaround the central lumen. In some embodiments, the central lumen can bedivided into compartments to form multiple lumens, such as with acentral spline, discussed further below. In some instances, the innerdiameter of the elongated structure may range from less than 1 mm tomore than 5 cm, such as from 3 mm to 2 cm, and including from 5 mm to 10mm.

The cross-sectional configuration of a surgical drain of the inventioncan be any suitable shape, such as round, oval, an oval shape withopposite pointed ends or flanges (e.g., a “football” shape),rectangular, square, cross, etc. The drain can also be formed into anysuitable configuration, as long as it defines a lumen of suitableconfiguration. Drain configurations of interest include, but are notlimited to: linear, spiral, coil, double helix, etc. In some embodimentsthe entire drain has the same configuration. In other embodiments, atleast a portion of the drain may have a different configuration, e.g., aspiral configuration in one segment of the drain, and a linearconfiguration in another segment of the drain. In some embodiments, theentire drain has the same diameter. In other embodiments, at least aportion of the drain has a different diameter from the remainder of thedrain, e.g., a smaller diameter than the remainder of the drain. In someembodiments, where the surgical drain has a branched configuration,discussed further below, the drain can have different diameters indifferent portions of the drain. For example, the proximal main portionof the surgical drain may have a larger diameter than the limbs, orbranching portions of the drain.

The elongated structure has a distal end that is configured to be placedinto a body cavity. In some embodiments, the distal end of the elongatedstructure can be placed into a body cavity during an open surgicalprocedure. A body cavity that is exposed during an open surgicalprocedure can be referred to as an “open body cavity”. In otherembodiments, the distal end of the elongated structure can be placedinto a body cavity during a minimally invasive procedure (e.g., with anendoscope), or can in some embodiments be inserted percutaneously. Themethods of placing the elongated structure in the body are discussedfurther below.

In some embodiments (e.g., in embodiments where the elongated structureis inserted percutaneously or with a minimally-invasive procedure), theelongated structure may be configured to have a smaller diameter priorto insertion, and assume a larger diameter when present in the bodycavity.

The elongated structure has a proximal end that is configured to beoutside of the body when the distal end is present in the body cavity.The proximal end of the elongated structure is configured to beconnected to a drainage apparatus, such as a chest drain, or drainagebag, e.g., in the case of a urinary drain. In some embodiments, theproximal end is configured to be connected to a suction device. In someembodiments, the proximal end may further include a valve, such as avalve to prevent body fluids from flowing back into the body, and alsoto prevent the entry of air from the environment, or contamination ofthe body cavity from the environment.

Drains are made of any suitable material, including but not limited to:silicone, polymers, thermoplastic elastomers, plastic, rubber,biodegradable material, metals, alloys, materials which can changeconfiguration or diameter or rigidity with application of ultravioletlight, or other form of electromagnetic energy, changes in temperature,for example, or any other suitable material, and combinations ormixtures thereof. In some embodiments, the material of the surgicaldrain is “preformed”. By “preformed” is meant that the tubing isconstructed of a material which allows the drain to have a preferredconfiguration, such as a spiral shape. A “preformed” shape may beachievable by polymers whose shape is determined by temperature, lightof any wavelength, or other energy source.

The surgical drain of the subject invention can include adiameter-varying element, which is an element that can significantlychange the diameter of the subject surgical drain. In addition to theability to change the diameter of a surgical drain, the diameter-varyingelement can provide hoop strength. By hoop strength is meant the abilityof a drain or tube to withstand pressure, bending or crushing forces.The diameter-varying element can change the surgical drain of thesubject invention from a larger diameter, which is referred to as an“expanded” state, to a smaller diameter, which can be referred to as a“collapsed” state. By “significantly change the diameter” of thesurgical drain is meant a change in diameter of at least 20%, such as atleast 30%, or at least 40%, or more than 50%, more than 70%, more than80%, more than 90%, or more than 99% etc. In some embodiments, thesignificant change in diameter can be a decrease in diameter, and insome embodiments, the significant change in diameter can be an increasein diameter.

The diameter-varying element can be a wire, a balloon filled with afluid, or a central spline, which embodiments are discussed furtherbelow. As such, the diameter-varying element is an element that can beinserted into or removed from a surgical drain (e.g., a wire), or it canbe an element that is altered when present in the surgical drain (e.g.,a balloon that is filled with a liquid). As such, the diameter-varyingelement can be present in a surgical drain when the drain is placed in abody cavity, or the diameter-varying element can be placed into asurgical drain after the drain has been placed in a body cavity.

For example, in some embodiments, the diameter-varying element is anelement that maintains the surgical drain in a larger diameter (e.g., apreformed wire), which decreases to a smaller diameter once thediameter-varying element is removed. In other embodiments, thediameter-varying element is an element that can change the diameter of asurgical drain from a larger diameter to a smaller diameter (e.g., astraight wire inserted into preformed spiral tubing) once thediameter-varying element is inserted. In yet another embodiment, thediameter-varying element is altered when present in a surgical drain todecrease the diameter of the surgical drain before removal (e.g., aballoon that can have the air removed). In some embodiments, thealteration or change in a diameter-varying element can be controlled byremote means, such as with a radiofrequency or other electromagneticsignal, magnetic induction, etc. or automatic means, such as with aprocessor, etc.

In some embodiments, there can be more than one diameter-varying elementin an elongated structure (e.g., more than one wire, such as two ormore, or three or more, etc.). In some embodiments, there can be morethan one type of diameter-varying element in an elongated structure(e.g., a wire and a balloon). In some embodiments, there can be acombination of diameter-varying elements in an elongated structure. Forexample, an elongated structure can have a central spline, which canfurther include balloons integrated into the central spline.

In some embodiments, the cross-sectional configuration of a surgicaldrain of the invention can change in cross-sectional configuration by amechanical change in a diameter-varying element (e.g., one or morewires, or a central spline, etc.) A mechanical change can includeshortening or lengthening of a diameter-varying element, or winding,unwinding, twisting, untwisting, etc. of a diameter-varying element. Insome embodiments, devices such as a slide, or a lock, a clip, etc., canbe used to hold a diameter-varying element in a particularconfiguration. For example, one or more wires in the wall of anelongated structure can be mechanically shortened such that the wiresdefine a larger cross-sectional area by “bowing”. The elongatedstructure can be held in the larger diameter configuration while in abody cavity by using a clip, for example, to hold the wires in thelarger diameter configuration. In another example, a diameter-varyingelement such as a central spline can be “wound” or “unwound” such thatthe central spline changes in cross-sectional configuration, e.g., froma tight spiral in the “wound” configuration, to a looser spiral in the“unwound” configuration. A central spline in the “wound” configurationcan also have a smaller diameter than a central spline in the “unwound”configuration. In some embodiments, the alteration or change in acentral spline can be controlled by remote means, such as with aradiofrequency or other electromagnetic signal, magnetic induction, etc.or automatic means, such as with a processor, etc.

The diameter-varying element, when present, may or may not be integratedwith the elongated structure. By integrated is meant that thediameter-varying element cannot be separated from the elongatedstructure without irreparably altering the elongated structure. Examplesof integrated configurations are where the diameter-varying element is aballoon integrated into the wall of the elongated structure, e.g., asdescribed in greater detail below. Examples of non-integratedconfigurations are where the diameter-varying element is a wire whichcan be separated from the elongated structure without comprising theelongated structure.

The diameter-varying element has a length sufficient to extend at leastalong the portion of the surgical drain that is inside the body cavity,such that the diameter-varying element provides a segment of the distalend of the surgical drain which can significantly change in diameterwhen present in the body cavity. For example, in certain embodiments,the diameter-varying element is present in the distal one third of asurgical drain. In some embodiments, the diameter-varying element ispresent in the distal half of a surgical drain. In some embodiments, thediameter-varying element is present along the entire length of thesurgical drain. Therefore, the length of the diameter-varying elementmay vary, ranging in some instances from less than one cm to 300 cm,such as from 5 cm to 90 cm, and including from 15 cm to 30 cm.

In some embodiments, the diameter-varying element is present in thesurgical drain when the surgical drain is initially placed in a bodycavity to be drained. In other embodiments, the diameter-varying elementis inserted into the surgical drain after the surgical drain has beenplaced into body cavity to be drained. Therefore, in some embodimentsthe diameter-varying element is present when the elongated structure isinitially placed in the body cavity, and in some embodiments, thediameter-varying element is inserted into the elongated structure afterthe elongated structure has been placed in the body cavity.

The surgical drain of the subject invention further includes a “wall”portion, and a “core” portion. By “wall portion” of the surgical drainis meant the portion of the elongated structure which surrounds thedrainage lumen, such that the wall surrounds the longitudinal axis ofthe drainage lumen. In some embodiments, therefore, the “wall” can havea cylindrical configuration. In some embodiments, the elongatedstructure can have a wall that defines more than one lumen, for example,the “wall” can have a “cross” configuration, with a lumen in the centerof the cross. In some embodiments, therefore, the “wall” can surround acentral drainage lumen, and can also define additional peripheral lumensaround the central lumen with portions of the wall that extend in aperpendicular orientation to the long axis of the elongated structure,(e.g., “arms” of the cross, as described further below). The walls ofthe peripheral lumens can therefore be partially formed by the bodytissue which surrounds the structure.

By “core” of the surgical drain is meant the portion of the elongatedstructure in the center of the drainage lumen, such that thelongitudinal axis of the core is parallel with the longitudinal axis ofthe drainage lumen. The elongated structure of the subject invention cantherefore include a wall portion and a core portion.

In some embodiments, the diameter-varying element is present in the wallportion of the elongated structure. In this embodiment, the elongatedstructure can have one or more fenestrations in the wall to allow fordrainage of body fluids through the wall of the elongated structure. Inother embodiments the “wall” can have a spiral configuration. In thisembodiment, the “wall” of the elongated structure may be viewed as asupport, in that the “wall” is not a continuous wall, but rather is asupport structure. In such embodiments, once the elongated structure isplaced in a body cavity, the walls are partially formed by the bodytissue which surrounds the structure. For example, the “wall” of theelongated structure may be formed of tubing in a spiral configuration,which may have a diameter-varying element inside the tubing (e.g., awire). In some embodiments, the diameter-varying element is present inthe core portion of the elongated structure. By “core portion” of thesurgical drain is meant the portion of the elongated structure in thecenter of the drainage lumen, such that the longitudinal axis of thecore is parallel with the longitudinal axis of the drainage lumen.

An embodiment of a surgical drain of the subject invention is shown inFIGS. 2A and 2B. FIG. 2A depicts a surgical drain 200 where the diameterhas been decreased throughout the entire length of the surgical drain.In this embodiment, surgical drain 200 includes a diameter-varyingelement along the entire length of the surgical drain. For example,surgical drain 200 may include balloons in the wall inflated with air.Once the air is removed from the balloons, the diameter is no longersupported by balloon inflation or other mechanism, and is now ready tobe withdrawn from the patient. In this example, the entire surgicaldrain is in the collapsed state, preventing any ingress of atmosphericair via the surgical drain itself, which traverses the skin andsubcutaneous tissues 210.

FIG. 2B shows another embodiment of surgical drain of the subjectinvention 220. In this embodiment, the diameter of the distal portion ofthe surgical drain has been reduced, while the wall of the proximalportion 230 of the subject surgical drain is constructed of a rigidmaterial surrounding the lumen of the drain that maintains its diameter.The proximal portion 230 with a fixed larger diameter facilitatesconnection to other devices, for example, a suction device, as discussedfurther below. In this embodiment, the surgical drain 220 includes adiameter-varying element in only the distal end of the diameter-varyingelement, e.g., the distal two-thirds of the surgical drain. In thisexample, therefore, only the distal portion of the surgical drain 225 isin the collapsed state. However, the decreased diameter of the distalportion of the surgical drain, which includes the portion of thesurgical drain which traverses the skin and subcutaneous tissues 210,prevents ingress of air into the surgical drain during withdrawal, andalso allows the distal portion of the device to be withdrawn withminimal pain and discomfort. Also shown in this figure is valve 205 forinflation and deflation of a diameter-varying element such as a balloon,and syringe 215.

Diameter-Varying Elements

As reviewed above, surgical drains of the invention may include adiameter-varying element. The diameter-varying element can beconstructed of any material suitable for use in the body that can beused in the devices and methods of the subject invention, e.g., draininga fluid from a body cavity. Diameter-varying elements may vary, whereexamples of diameter-varying elements include, but are not limited to:wires, balloons, central spines, etc. Examples of variousdiameter-varying elements are now reviewed in greater detail below.

Wires

In some embodiments, the diameter-varying element is a wire. The wire inthis embodiment can be made of a variety of biocompatible polymericmaterials or metallic materials that combine flexibility ormalleability, high strength, and high fatigue resistance. For example,the diameter-varying element can be formed using materials including,but not limited to: metals including stainless steel, titanium, alloysincluding a nickel-titanium alloy, a nickel-cobalt alloy, another cobaltalloy, tantalum, shape-memory materials, polymers, elastomers, polymeror elastomer blends and copolymers, elastic or superelastic materials,and combinations and mixtures thereof. The wires may also be coated,e.g., with a friction-reduction coating.

The cross-sectional configuration of the diameter-varying element in theform of a wire can be any suitable shape, such as round, oval,rectangular, square, etc. In some embodiments, the wire may have aflattened cross-sectional shape, such as a “ribbon” shape, and in someembodiments, the wire may be braided. The wire can also be formed intoany suitable configuration, such as a straight line, a spiral, a doublespiral, a triple spiral, etc., a coil, etc. In some embodiments, therecan be more than one wire, such as two or more, three or more, etc. Insome embodiments, the cross-sectional configuration of diameter-varyingelement in the form of a wire can change in cross-sectionalconfiguration by a mechanical change, as disclosed above. For example,one or more wires in the wall of an elongated structure can bemechanically shortened such that the wires define a largercross-sectional area by “bowing”. The elongated structure can be held inthe larger diameter configuration while in a body cavity by using aclip, for example, to hold the wires in the larger diameterconfiguration. In another example, a group of wires can be “wound” or“unwound” such that the wires change in cross-sectional configuration,e.g., from a tight spiral in the “wound” configuration, to a looserspiral in the “unwound” configuration. The lumen defined by the wires inthe “wound” configuration can also have a smaller diameter than thelumen defined by the wires in the “unwound” configuration. In someembodiments, the alteration or change in a diameter-varying element canbe controlled by remote means, such as with a radiofrequency or otherelectromagnetic signal, magnetic induction, etc. or automatic means,such as with a processor, etc.

In some embodiments the entire wire has the same configuration, and inother embodiments, at least a portion of the wire may have a differentconfiguration, e.g., a spiral configuration in one segment of the wire,and a linear configuration in another segment of the wire. In someembodiments, the entire wire has the same diameter. In otherembodiments, at least a portion of the wire has a different diameterfrom the remainder of the wire, e.g., a smaller diameter than theremainder of the wire. In some embodiments, where the surgical drain hasa branched configuration, discussed further below, the wire can alsohave a branched configuration. The diameter and length of the wire willdepend on the size and configuration of the surgical drain.

In some embodiments, the wire is “preformed”. By “preformed” is meantthat the wire is constructed of a material, such as a shape memorymaterial, which allows the wire to have a preferred configuration.Suitable material for securing members can include shape memorymaterials, which are materials that have a temperature induced phasechange, e.g., a material that if deformed when cool, returns to its“undeformed”, or original, shape when warmed. Suitable material includesbut is not limited to metals such as a nickel-titanium (NiTi) alloy(e.g., nitinol), a nickel-cobalt alloy, another cobalt alloy, alloys ofCuZnAl, a thermoset plastic, stainless steel, a suitable biocompatibleshape-memory material, a suitable biocompatible superelastic material,combinations thereof, and any suitable biocompatible shape memory alloy.In some embodiments, both the wire and the tubing can be preformed,e.g., both the wire and the tubing can be preformed into a spiralconfiguration.

FIGS. 3A and 3B show an embodiment of a surgical drain in which thediameter-varying element is a wire. FIG. 3A illustrates surgical drain300 with a wire 310 in a straight configuration, which has been placedinside tubing 320. In FIG. 3B, the wire has been “preformed” into aspiral configuration, such that the tubing 320, which is supported bythe wire, also forms a spiral configuration. Because the wire has beenpreformed into a spiral configuration, this facilitates the deformationof the small diameter tubing 320 into a functioning cylindrical drain305 with a lumen whose diameter is much larger than either the wire orthe small diameter tubing. When the surgical drain with thisconfiguration is placed into a body cavity, the surrounding tissuescomplete the “wall” around the cylindrical drain. The application ofsuction or gravity drainage 340 to the proximal end of the drain whichis external to the body results in the removal of air, liquid, solid orsemi-solid material from the desired body cavity or space.

The embodiment of the surgical drain as shown in FIGS. 3A and 3Billustrates how the initial small diameter drain in FIG. 3A istransformed into the much larger diameter functioning surgical draindepicted in FIG. 3B by the insertion of a preformed wire. Although FIG.3B is shown as a continuous wire, this embodiment could also include twopreformed wires 310 coiled into a spiral configuration to deform twotubes 320 into a cylinder with a plurality of fenestrations 330. Inanother embodiment, the same functional result, e.g., a cylindricaldrain with a much larger diameter with multiple fenestrations as shownin FIG. 3B, is constructed of preformed small diameter tubing. In thisembodiment, small diameter tubing is used, where the tubing is formed ofa material whose preformed shape forms a large functioning diameter tubeor drain. In this embodiment, the diameter-varying element, e.g., astraightening wire, is inserted to reduce the diameter of the overallfunctioning cylindrical drain to the smaller diameter tubing at the timeof insertion or withdrawal when the smaller diameter is desired.

FIG. 4 is another embodiment of a surgical drain where thediameter-varying element is a preformed wire 410 inserted into tubing420 thereby creating a cylinder draining the pleural cavity 450. Asdepicted, the wire 410 is partially withdrawn from the tubing (shown aselement 425) which leaves the distal portion of the surgical drainformed by the spiral tubing unsupported by the wire 420. Removal ofpreformed wire 410 therefore results in the straightening of tubing 420,such that the surgical drain formed by the tubing alone now has a muchsmaller diameter, shown as straightened tubing 425. When removal of wire410 is complete, the smaller diameter surgical drain can be removed fromaround lung 480 with significantly less pain detected by nerve endingsin the pleural cavity 450, the intercostal nerve bundles 460 and theskin and subcutaneous tissues 470.

The surgical drain embodiment in FIG. 5A is similar to the surgicaldrain shown in FIG. 4, except that in this embodiment, the smalldiameter tubing 520 has flanges, which increase the width of the tubingcreating the cylindrical space of the surgical drain. In FIG. 5B, theembodiment of two preformed wires 510 inside two flanged tubes 520 isshown as a functioning surgical drain. In this embodiment, thecylindrical shape of the surgical drain with fenestrations 530 iscreated by the preformed wire 510 inside small diameter flanged tubing520. The lumen formed by the tubing and wire can be used to remove air,body fluids, blood or clots. etc. from pleural space 550.

Balloons

In some embodiments, the diameter-varying element is a balloon. Theballoon in this embodiment can be made of a variety of biocompatiblepolymeric materials or metallic materials that combine flexibility, highstrength, and expandability. For example, the balloon can be formedusing materials including, but not limited to: silicon, latex,polyurethane, polyimide or any other expandable and elastomericmaterial, and combinations or mixtures thereof.

The balloons can be filled with any material suitable for expanding theballoons, including but not limited to liquids, gasses, air, foam,including self-inflating foam material such as foamed polyurethane, orsimilar material. A self-inflating foam type material that can be usedwith the surgical drains of the subject invention can have a pluralityof interconnected air pockets, such that a balloon can be deflated byusing a syringe or other similar device to withdraw air out of theself-inflating foam.

The cross-sectional configuration of the diameter-varying element in theform of a balloon can be any suitable shape, such as spiral, coiled,linear, round, oval, rectangular, square, etc. In some embodiments, aplurality of balloons can be in the cross-sectional shape of “spokes ona wheel”, for example, in which one or more balloons extend along thelength of the elongated structure, and then extend out in a directionperpendicular to the long axis of the elongated structure. In someembodiments, one or more balloons can extend from the wall of theelongated structure at an angle, such as 25 degrees, 45 degrees, 65degrees, etc. In some embodiments, the balloon may have a flattenedcross-sectional shape, such as a “ribbon” shape. In other embodiments,the balloon may be a combination of shapes, such as for example, aballoon can have a spiral portion and a linear portion. The dimensionsof a balloon may vary depending on the location of the balloon, thenumber of balloons in a particular surgical drain, and the size of thesurgical drain. In some embodiments, the entire balloon has the samediameter. In other embodiments, at least a portion of the balloon has adifferent diameter, e.g., a smaller diameter. In some embodiments, atleast a portion of the balloon may have both a different configurationand a different diameter, e.g., a portion of the balloon may have asmaller diameter and a spiral configuration, and the portion of theballoon may have a larger diameter and a linear configuration. In someembodiments, where the surgical drain has a branched configuration,discussed further below, the balloon can also have a branchedconfiguration. The diameter and length of the balloon will depend on thesize and configuration of the surgical drain. In some embodiments, therecan be more than one balloon, such as one or more, or two or more, orthree or more, etc.

In some embodiments, the cross-sectional configuration of thediameter-varying element in the form of a balloon can change incross-sectional configuration by a mechanical change, such as winding,unwinding, twisting, untwisting, shortening or lengthening, etc. asdisclosed above. In some embodiments, devices such as a slide, or alock, a clip, etc., can be used to hold one or more balloons in aparticular configuration, or can be used to seal a valve or syringe inorder to maintain the balloons in an altered configuration. In someembodiments, the alteration or change in a diameter-varying element canbe controlled by remote means, such as with a radiofrequency or otherelectromagnetic signal, magnetic induction, etc. or automatic means,such as with a processor, etc.

An embodiment of a surgical drain where the diameter-varying element isa balloon is depicted in FIGS. 6A and 6B. In this embodiment, theincreased diameter of the surgical drain is created by insufflation ofair into a coiled balloon 690. The air is insufflated through a one-wayvalve 605 with a syringe 615. Other fluids such as a liquid (e.g.,saline), other gas, or a foam can also be used to inflate the balloons.FIG. 6A illustrates a single balloon in a spiral configuration. FIG. 6Bshows dual balloons in a spiral configuration arranged in opposingcoils, which creates fenestrations 630 allowing the application ofsuction 640 to the drain. Although two balloons are shown in FIG. 6B,embodiments of the invention include use of more than two balloons, suchas three or more, or four or more, etc. In addition, embodiments caninclude a combination of diameter-varying elements, e.g., balloons,wires, etc.

FIGS. 7A-7C depict another embodiment of a surgical drain where thediameter-varying element is a plurality of balloons 790, which can beinsufflated with air through a one-way valve 705 from syringe 715. FIG.7A depicts surgical drain 700 where the diameter has been decreasedthroughout the entire length of the surgical drain. In this embodiment,surgical drain 700 includes a diameter-varying element (e.g., one ormore balloons) along the entire length of the surgical drain, where theballoons are integrated into the wall of the elongated structure of thedrain. FIG. 7B shows another embodiment of surgical drain 720. In thisembodiment, the diameter of the distal portion of the surgical drain hasbeen reduced, while the proximal portion 730 is constructed of a solidmaterial that maintains its diameter. In other words, this portion ofthe surgical drain does not contain a diameter-varying element. Theproximal portion 730 with a fixed larger diameter facilitates connectionto other devices, for example, a drainage apparatus, as discussedfurther below.

In FIG. 7C, the diameter-varying element in the form of a plurality ofballoons 790 has been inflated with a fluid (e.g., foam, air, liquid)through one-way valve 705 from syringe 715. In this embodiment,inflation of the balloons results in a significant increase in thediameter of the surgical drain. The balloons in this embodiment arelocated in the wall of the surgical drain (i.e., integrated into thewall of the elongated structure), such that a ring of eight balloons,shown as element 795, are connected to form the wall of the elongatedstructure forming the surgical drain.

A cross-sectional view of the surgical drain as shown in FIG. 7C isfurther illustrated in FIG. 8A. In this embodiment, the increaseddiameter of the drain while the drain is functioning is supported by aplurality of balloons 890 filled with self-inflating foam 835. FIG. 8Bshows a cutaway view of the same embodiment. Connecting hoopstrengthening elements 845 between balloons 890 create fenestrations830. The presence of fenestrations allows for egress of drained materialwhile the drain in placed in a body cavity. When the drainage functionis no longer desired, the air or other gas contained in the balloonsfilled with self-inflating foam is aspirated via a syringe and one-wayvalve. The diameter of the drain is thus greatly reduced and the draincan be withdrawn with a significant decrease in the pain experienced bythe patient.

FIGS. 9A and 9B depict an embodiment of the invention where theelongated structure consists of a “wall” in a cross-shapedconfiguration, where the diameter-varying element (e.g., balloons, shownas element 990) are in the wall of the elongated structure, as shown inFIG. 9A. In this embodiment, there is a central drainage lumen, shown aselement 965, which further has fenestrations 930. Also shown is a wire995 present in the central drainage lumen, an embodiment which isdiscussed further below. The central lumen may or may not have a wire,e.g., a guidewire. In this embodiment, the “wall” also defines fourperipheral lumens, as discussed above, shown as element 966 inside thedotted line. The walls of the peripheral lumens are partially formed byadjacent “arms” of the cross, and partially formed by the surroundingbody tissue when the elongated structure is placed in a body cavity.Therefore, in this embodiment there are five drainage lumens. FIG. 9Bdepicts the same embodiment, with the difference being that in FIG. 9Bthe diameter-varying element (e.g., the balloons in the wall of theelongated structure 990) has been deflated by aspirating air via asyringe 915 connected through one-way valve 905. The deflated elongatedstructure is withdrawn, which results in decreased pain for the patienttransmitted via the intercostal nerve bundles 960 and skin andsubcutaneous tissues 970.

Central Spline

In some embodiments, the diameter-varying element is a central spline. Acentral spline is an elongated flexible member that can be inserted orremoved from the core portion of a surgical drain, thereby providing aflexible, internal soft support. The central spline in this embodimentcan be made of a variety of biocompatible polymeric materials ormetallic materials including, but not limited to: silicone, polymers,thermoplastic elastomers, plastic, rubber, biodegradable material,metals, alloys, any other suitable material, and combinations ormixtures thereof.

The cross-sectional configuration of the diameter-varying element in theform of a central spline can be any suitable shape, such as a cross,round, oval, rectangular, square, etc. In some embodiments, the centralspline can have one or more additional diameter-varying elements, suchas a wire, or one or more balloons. The additional diameter-varyingelement, such as a balloon, can be in the center of the central spline,or around the edges of the central spline. The diameter-varying element,when present, may or may not be integrated with the central spline. Byintegrated is meant that the diameter-varying element cannot beseparated from the central spline without irreparably altering thecentral spline. Examples of non-integrated configurations are where thediameter-varying element is a wire which can be separated from thecentral spline without comprising the central spline. In someembodiments, the central spline itself can therefore change in diameter.For example, one or more balloons integrated into a central spline canbe deflated before the central spline is removed. In other embodiments,the central spline may be a combination of shapes, such as for example,a central spline which has the cross-sectional configuration of a crossin one portion of the spline, and a round configuration in anotherportion of the spline. In some embodiments the entire spline has thesame shape, and in other embodiments, at least a portion of the splinemay have a different shape.

In some embodiments, the entire spline has the same diameter. In otherembodiments, at least a portion of the spline has a different diameterthan the remainder of the spline, e.g., a smaller diameter than theremainder of the spline. In some embodiments, at least a portion of thespline may have both a different configuration and a different diameter,e.g., a portion of the spline may have a cross-sectional configurationin a cross, with a larger diameter, and a potion of the spline may havea round cross-sectional configuration, with a smaller diameter.

In some embodiments, the cross-sectional configuration of a centralspline can change in cross-sectional configuration by a mechanicalchange, such as winding, unwinding, twisting, untwisting, shortening orlengthening of the central spline, etc. In some embodiments, devicessuch as a slide, or a lock, a clip, etc., can be used to hold a centralspline in a particular configuration. For example, a central spline canbe “wound” or “unwound” such that the central spline changes incross-sectional configuration, e.g., from a tight spiral in the “wound”configuration, to a looser spiral in the “unwound” configuration. Acentral spline in the “wound” configuration can also have a smallerdiameter than a central spline in the “unwound” configuration. In someembodiments, the central spline can include one or more flanges, wings,paddles, appendages, etc., which can be deployed in the larger diameterconfiguration and retracted or overlapped in the smaller diameterconfiguration. In some embodiments, the alteration or change in adiameter-varying element can be controlled by remote means, such as witha radiofrequency or other electromagnetic signal, magnetic induction,etc. or automatic means, such as with a processor, etc.

In some embodiments, when the diameter-varying element is a centralspline, the central spline may further be attached to the proximal orthe distal end of the surgical drain, such that it can be withdrawn withthe surgical drain, or it can be inverted and withdrawn, depending onthe point of the attachment. In these embodiments, the surgical drainwould be made of material sufficiently flexible to invert. In someembodiments, where the surgical drain has a branched configuration,discussed further below, the spline can have a branched configuration.The diameter and length of the spline will depend on the size andconfiguration of the surgical drain.

FIGS. 10A and B show an embodiment of the invention in which thediameter-varying element is a central spline. In this embodiment, asurgical drain 1020 perforated with fenestrations 1030 is supported by acentral spline 1075. Central spline 1075 is an internal soft supportconfigured to be placed in the lumen of an elongated structure, such assurgical drain 1020. The cross-sectional shape of central spline 1075 inFIG. 10A is in the form of a cross. The central spline can in someembodiments include balloons, such as the four balloons 1090 shown inthe central spline 1075, which can be inflated during the period thedrain is functioning in order to provide a larger diameter. In thisembodiment, the central spline has a central drainage lumen, shown aselement 1065, which may or may not have a wire present in the lumen,e.g., a guidewire. In this embodiment, the central spline divides thelumen of the elongated structure into sections, such that there are fourperipheral lumens (element 1066) created by the central spline, inaddition to the central lumen 1065.

FIG. 10B depicts the withdrawal of the diameter-varying element orcentral spline when the larger diameter is no longer necessary. Theinternal supporting structure provided by the central spline is simplywithdrawn if constructed of soft solid material. In this embodiment,prior to removal of the drain, the balloons 1090 in the central spline1075 can also be deflated. The surgical drain 1020 is then withdrawn inits collapsed state. In some embodiments, when the diameter-varyingelement is a central spline, the central spline may further be attachedto the proximal end or the distal end of the surgical drain, such thatit can be withdrawn with the surgical drain, or it can be inverted andwithdrawn, depending on the point of the attachment.

Branches

In some embodiments, the surgical drain of the subject invention mayfurther comprise branches. By “branches” or “limbs” is meant one or moreextensions, or limbs, of the main portion of the surgical drain that canincrease drainage capacity of a surgical drain of the subject invention.For example, in draining a body cavity in the chest, one branch or limbcan be placed in the upper portion of the chest, and another branch canbe placed at the base of the chest. A surgical drain can therefore havetwo or more branches, or three or more branches, or four or morebranches, etc. The branches may, in some embodiments, have a diameterthat is smaller than the diameter of the proximal portion of thesurgical drain.

In some embodiments, when the diameter-varying element employed is awire, the limbs of a surgical drain may be positioned either by usingwire that has been pre-formed into a desired shape, or by usingmalleable wire. In addition, any of the embodiments of wires asdisclosed above can be used in the creation and placement of branches ofa surgical drain. In other embodiments, any suitable pre-formed ormalleable polymer, plastic, or similar material can be used to provideplacement accuracy for the branches of the surgical drain. As discussedabove, in some embodiments, the diameter-varying element employed in asurgical drain of the subject invention can be a balloon, or a centralspline.

FIG. 11 illustrates an embodiment of the surgical drain in the chestcavity, showing that a plurality of diameter-varying elements in theform of multiple wires can be used to define additional branches of thesurgical drain. The plurality of drainage limbs 1125 (in this example,two branches are shown) are in continuity with the proximal portion ofthe surgical drain which exits the body cavity and skin 1170. Thisembodiment is similar to the embodiment of the surgical drain as shownin FIGS. 3A-4, in that each branch of the drain is formed by tubing 1120through which preformed wires 1110 are inserted. The tubes 1120 areformed into a branch which has a larger effective diameter for thedrainage lumen than a single tube alone would create. The branch 1125has a plurality of fenestrations 1130. The wires can be malleable suchthat the branches of the surgical drain can be positioned in specificlocations, in order to achieve wide drainage. For example, as shown inFIG. 11, one branch 1125 extends superiorly to evacuate air from theupper portion of the thoracic cavity, and the lower branch extendsinferiorly to drain or evacuate body fluids, blood or clot from thelower portion of the thoracic cavity. However, in this embodiment, bothbranches can drain both fluid and air. When drainage is no longerdesired, the collapsible nature of the branches allows for withdrawal ofthe reduced diameter(s) of the surgical drain through a single skinincision 1171. Also shown are the pleural cavity 1150, lung 1180, andthe intercostal nerve bundles 1160.

FIG. 12 illustrates another embodiment of a surgical drain with branchesplaced in the chest cavity, shown in a lateral view. In this embodiment,the surgical drain includes two drainage limbs 1225 within the pleuralspace, one placed superiorly, and one placed inferiorly. Also shown inthis figure is valve 1205 for inflation and deflation of adiameter-varying element such as a balloon, and syringe 1215. A similarview is shown from the anterior posterior view in FIG. 13. The elementof another diameter-varying element, such as a wire, which providessupport to the surgical drain, can also allow malleability andsteerability of the one or more branches 1325 of the surgical drain.However, prior to the time of withdrawal of the surgical drain, thelimbs can be collapsed to minimize contact with the pain nerve endings.These nerves can be found in the pleural cavity 1350, at the intercostalnerve bundles 1360 and at the skin and subcutaneous tissues 1370.Further, the embodiment of the surgical drain of the subject inventioncan be withdrawn through a single skin incision, thus minimizing thenumber of skin and subcutaneous pain nerve endings exposed to thesubject surgical drain while the drain is indwelling and during removal.

FIGS. 14A-B are schematic views in the anterior to posterior projectionof the entire thoracic cavity showing the wide drainage achievable withsubject surgical drain. A plurality of limbs 1425 can be used, and inthis example four limbs are shown. These limbs of the surgical drainhave been placed in order to optimize drainage of the pericardial spaceand mediastinum 1403 and pleural cavity 1450. In this view, the surgicaldrains are in their expanded state. In this embodiment, thediameter-varying element is shown as wire 1410 inside tubing 1420. Thisextensive drainage can be achieved via a drain that exits the skin 1471in one location, because the surgical drain is collapsible. FIG. 14B isanother schematic view in the same anterior to posterior projection ofthe entire thoracic cavity, with the branches 1425 depicted in thecollapsed state, after removal of wire 1410, as the drain is readied forwithdrawal via the single skin incision 1471. In another embodiment, thebranched elongated structure as shown in FIG. 14B can also includecollapse of the entire drain structure, i.e, both branches 1425 and thecentral proximal portion of the drain 1426 which traverses skin incision1471.

Delivery Lumen

In some embodiments of the invention, the surgical drain includes, inaddition to the lumen configured to drain a substance from a bodycavity, an additional lumen in the wall of the elongated structureconfigured to deliver a substance into the body cavity. Substances thatcan be delivered into the body cavity through an additional lumen caninclude pharmaceutical agents such as antibiotics, anti-clotting agents,anesthetic agents, etc. Pharmaceutical agents can be administered whilethe drain is in place. For example, they can be administeredcontinuously or intermittently for therapeutic treatment of infection,for example. In other embodiments, pharmaceutical agents can beadministered in a single dose, for example, if it is desired toadminister an anesthetic agent along the tract of the drain prior towithdrawal of the drain. In some embodiments, there can be more than onelumen. The lumen configured for delivery of a therapeutic substance,such as a pharmaceutical agent, can have a valve on the end, and can beattached to a syringe for delivery of the agent. In some instances, suchlumens are in fluid flow relationship with a source of the therapeuticagent, e.g., a fluid reservoir of the therapeutic agent. Such source maybe positioned at any convenient location, such as the proximal end ofthe surgical drain.

FIG. 15 is a schematic of the invention showing the proximal portion ofthe drain, which exits the pleural cavity and is fixed to the skin 1570.This embodiment shows the incorporation of tubing 1512 into the device.The tubing 1512 may be present throughout the entire length of thedevice, or the tubing may be present only in a portion of the device,e.g., in the proximal third, or the proximal half of the surgical drain,etc. Medications to treat disease may be given via tubing 1512 andsyringe 1513, which serves as the source of a therapeutic agent. Asshown in the figure, syringe 1513 is positioned at the proximal end ofthe drain. In addition, medications to provide local anesthesia may beadministered prior to removal of a surgical drain to decrease the painassociated with withdrawal of the device.

Coating

The surgical drain of the subject invention can also include a coatingaround a surface of the surgical drain. By “coating” is meant asubstance that is applied to a surface of a surgical drain or sheath. Insome embodiments, the coating may be a coating that reduces friction,such as a friction-reduction coating, or it may be a coating thatcontains a pharmaceutical agent, e.g. an agent that decreases the riskof blood clot formation, a coating that decreases the risk of infection,a coating that decreases pain, etc.

In some embodiments, the elongated structure may include afriction-reduction coating. Substances that may be used in afriction-reduction coating can include, but are not limited to: lowfriction polymers such as fluoro-ethylene copolymer (FEP), other lowfriction coatings that include paralyne, silicone, Teflon® coating, etc.In some instances, the presence of a friction-reduction coating on theoutside of a surgical drain decreases patient discomfort with removal ofthe drain. In instances, the presence of a friction-reduction coating onthe inside surface of a surgical drain improves the function of thesurgical drain, for example by decreasing the chances of a surgicaldrain becoming clogged by draining substances. A friction-reductioncoating on the inside surface of a surgical drain could also thediameter of a surgical drain to be reduced while preserving the samecapacity for drainage.

Methods of Using a Surgical Drain

Aspects of the invention further include methods of using a surgicaldrain in accordance with the invention, e.g., as described above, todrain a substance from a body cavity. The methods of using a surgicaldrain of the subject invention can include positioning a distal end ofan elongated structure in a body cavity, draining a substance from thebody cavity, decreasing the diameter of the distal end of the elongatedstructure prior to removal of the elongated structure, and then removingthe distal end of the elongated structure from the body cavity.

The distal end of a surgical drain of the subject invention can bepositioned in the body cavity during an open surgical procedure, duringa minimally invasive procedure (e.g., with an endoscope), or can in someembodiments be inserted percutaneously. The methods of the subjectinvention can also include the use of imaging guidance, such as xray,fluoroscopy, CT, ultrasound, MRI, nuclear medicine, etc., as well asother methods of visualization such as fiberoptic visualization, orendoscopic visualization. Furthermore, the methods can includeprocedures performed in a medical setting such as a hospital, clinic,office, radiology or fluoroscopy suite, and can also include proceduresperformed anywhere medically necessary, e.g. a battlefield.

By “open surgical procedure” is meant a surgery which is performedthrough a surgical incision allowing access and visualization of theportion of the body of interest. In some embodiments, the distal end ofthe elongated structure can be placed into a body cavity during an opensurgical procedure. A body cavity that is exposed during an opensurgical procedure can be referred to as an “open body cavity”.

By “minimally invasive surgical procedure” is meant a surgery which isperformed through a surgical incision or body opening that is smallerthan the incision required for an open surgical procedure. A minimallyinvasive surgical procedure generally includes the use of one or moreendoscopic instruments for allowing access and visualization of theportion of the body of interest. By “endoscope” or “endoscopicinstrument” is meant a thin tube-like instrument used to examine orenter the inside of the body of a subject, e.g., the thoracic cavity. Anendoscope can have a light and a lens or camera for viewing the insideof the body, and can also have one or more tools that can be used withan endoscope, such as a tool that can be used to place a surgical drain,or place a sheath over a drain, etc. One or more openings, or “ports”can be created in one or more locations in the body, e.g., theintercostal spaces of the chest, depending on the procedure to beperformed and the endocoscopic instruments to be used. One or moreendoscopes or endocoscopic instruments can be advanced through at leastone of the endoscopic body openings. In some embodiments, the distal endof the elongated structure can be placed into a body cavity during aminimally invasive surgical procedure.

By “percutaneously” is meant insertion of a surgical drain through askin incision or body opening that can be smaller than the incisionrequired for an open surgical procedure or a minimally invasiveprocedure. The skin opening can be just large enough to allow thesurgical drain to be inserted into the body cavity. In this embodiment,placement of a surgical drain can also be achieved by percutaneouslycreating an opening into a body cavity through a skin incision, andusing implements such as a needle, trocar, cannula, introducer, sheath,dilator, or the like through the opening. Percutaneous placement caninclude non-guided techniques or guided techniques including but notlimited to the use direct visualization, such as fiberopticvisualization, or endoscopic visualization, or imaging guidance asdiscussed above.

The step of draining a substance from the body cavity using the subjectsurgical drains can include allowing a body fluid, e.g., a liquid, air,blood, or other substance to drain from a natural or created bodycavity. Draining a body cavity can be performed for as long as necessaryfor a therapeutic effect; e.g., until the body cavity ceases to drain,or until the supervising physician or other healthcare providerdetermines that the drain is no longer necessary. Drainage of a bodycavity can occur over a period of minutes, hours, days, weeks, months oryears, depending on the medical condition.

The devices of the subject invention can be used for insertion into anybody cavity in need of draining, such as a thoracic body cavity, whichincludes a body cavity in the chest including a pleural body cavity orpericardial body cavity, an abdominal body cavity, a gastrointestinalbody cavity, a pelvic body cavity, a genitourinary body cavity, a cavityin the brain or spinal cord, a cavity in an extremity such as an arm orleg, etc. Further, the body cavity can be an anatomical or “natural”body cavity, e.g., the pleural space, or peritoneal space, or it can bea surgically-created or disease-created body cavity, e.g., an abscesscavity. In some embodiments, the body cavity can be a cavity in a solidorgan, (e.g., liver, bone, etc.) In some embodiments, the body cavitycan be a hollow organ, or an organ with a lumen, such as a urethra, aureter, a portion of the intestine, the esophagus, the trachea, or abronchial tube. Further, the devices can be inserted through an orificeand/or through an incision in the skin.

The subject surgical drain, during use, is maintained in the largerdiameter while present in the body cavity in order to provide thelargest area for drainage of the substance from the body cavity. Priorto removal of the surgical drain, the diameter of the distal end of thesurgical drain is decreased, which allows for easier removal of thesurgical drain, and significantly decreases patient discomfortassociated with the procedure.

As discussed above, the change in diameter of the distal end of thesurgical drain is mediated by a diameter-varying element. The change indiameter may be mediated by a diameter-varying element in a number ofdifferent ways. For example, the diameter may be changed by introducingthe diameter-varying element into the drain. Alternatively, thediameter-varying element may be changed by removing the diameter-varyingelement from the drain. These examples are not limiting, and embodimentsof mediation of diameter change by a diameter-varying element aredescribed further in greater detail below.

In some embodiments, decreasing the diameter of the elongated structurecomprises inserting a diameter-varying element into the elongatedstructure before the elongated structure is removed from the bodycavity. For example, in the case of a surgical drain made of a preformedtubing in a spiral configuration, the diameter-varying element can be awire in a straight configuration that, when inserted into the tubing inthe wall of the surgical drain, will straighten the spiral tubing,thereby decreasing the overall diameter of the surgical drain.

In some embodiments, decreasing the diameter of the elongated structurecomprises removing a diameter-varying element from the elongatedstructure before the elongated structure is removed from the bodycavity. For example, in the case of a surgical drain made of a preformedwire inside tubing, where the wire is in a spiral configuration, thediameter-varying element in this embodiment is the wire in a spiralconfiguration. The spiral configuration of the wire which deforms thetubing into a spiral configuration results in a larger diameter of thesurgical drain while the surgical drain in present in the body cavity.Once the preformed wire in a spiral configuration is removed from thetubing, the tubing will straighten, thereby decreasing the overalldiameter of the surgical drain. In another example, a surgical drain canhave a central spline in the core portion of the surgical drain, whichcreates a larger diameter while the surgical drain is present in thebody cavity. Once the central spline is removed from the core portion ofthe surgical drain, the unsupported wall of the surgical drain willdecrease in diameter.

In some embodiments, the diameter-varying element is present in the wallportion or the core portion of a surgical drain and is altered beforethe surgical drain is removed from the body cavity. For example, in thecase of a surgical drain in which the diameter-varying element includesone or more balloons filled with foam in the wall portion of thesurgical drain, the filled balloons in the wall result in an expandedwall portion of the surgical drain, and therefore a larger diameter ofthe drain while the surgical drain in present in the body cavity. Oncethe foam is removed from the balloons, the surgical drain will decreasein size, thereby decreasing the overall diameter of the surgical drain.

In some embodiments, therefore, the diameter of the elongated structureis decreased before positioning the elongated structure in a bodycavity, and increased after being positioned in a body cavity. In someembodiments, the diameter of the elongated structure is decreased beforewithdrawing the elongated structure from the body cavity. In someembodiments, the diameter of the elongated structure can be changed froma larger diameter to a smaller diameter and back again while the distalend of the elongated structure is positioned in a body cavity. In otherembodiments, the diameter of the elongated structure can be changed froma large diameter to an even larger diameter to increase drainage surfacearea while the distal end of the elongated structure is positioned in abody cavity. In some embodiments, the change in diameter can beperformed more than once, for example, such as two or more times, orthree or more times, etc., while the elongated structure is positionedin a body cavity. Changes in diameter can be performed to improvedrainage of thicker material from the elongated structure, e.g., removalof clots, debris. For example, a diameter-varying element can beinserted, or removed, or altered as disclosed above while the elongatedstructure is indwelling in the body. In some embodiments, change indiameter can be by mechanical means, as disclosed above. In someembodiments the change in diameter mediated by the diameter-varyingelement can be controlled by remote or automatic means.

Methods of draining a substance from a body cavity can also includemethods of using the subject sheaths (described in greater detail below)with the subject surgical drains or other drains for draining asubstance from a body cavity. The sheath of the subject invention can beplaced around a surgical drain such as those disclosed in the presentapplication, or the sheath can be placed around any suitable surgicaldrain, tube, or cannula. Methods of using the subject sheaths aredescribed further below.

FIG. 28 is a schematic of a subject surgical drain showing percutaneousinsertion of the surgical drain. In this embodiment, the surgical drainis being introduced into the pleural cavity 2850 using implements forpercutaneous insertion, including guidewire 2821 and introducer sheath2822. The surgical drain tubing 2820 and preformed wire 2810 are alsoshown. In this embodiment, percutaneous insertion of the surgical draincan be performed using any suitable technique, such as the Seldingertechnique. The guidewire is inserted through the needle after the localtract has been anesthetized. The anesthetized tract can then be dilatedwith dilators placed over a guidewire before inserting the smalldiameter introducer sheath 2822 over the guidewire 2821. The surgicaldrain can be placed into a body cavity while the surgical drain is stillin the collapsed, or unsupported small diameter state, which allows fora smaller skin incision and a smaller tract through the tissue. Afterplacement of the surgical drain into the thoracic cavity, the surgicaldrain can be expanded to larger diameter configuration. Also shown areskin and subcutaneous tissue 2870, intercostal nerve bundles 2860,pleural cavity 2850, and lung 2880.

The surgical drain in a larger diameter of the surgical drain in theexpanded configuration allows the surgical drain to function like alarge bore drain inserted in open procedures under general anesthesia.The larger diameter results in better drainage with more efficientevacuation of air, body fluids and or semi-solid or solid material thanwould be possible with a smaller diameter drain. When the desiredfunction of the large diameter drain is no longer required, the surgicaldrain is withdrawn. The withdrawal process involves decreasing thediameter of the surgical drain by mediating the diameter-varying element(e.g., removing a preformed wire, or deflating a balloon, etc.). Oncethe surgical drain has reached the small diameter configuration, thesurgical drain is removed.

The description of the present invention is provided herein in certaininstances with reference to a subject or patient. As used herein, theterms “subject” and “patient” refer to a living entity such as ananimal. In certain embodiments, the animals are “mammals” or“mammalian,” where these terms are used broadly to describe organismswhich are within the class mammalia, including the orders carnivore(e.g., dogs and cats), rodentia (e.g., mice, guinea pigs, and rats),lagomorpha (e.g., rabbits) and primates (e.g., humans, chimpanzees, andmonkeys). In certain embodiments, the subjects, e.g., patients, arehumans.

Sheaths

Aspects of the invention further include surgical sheaths. Sheaths forsurgical drains according to certain embodiments of the invention aredevices that are configured to be disposed around a cylindricalstructure, such as a surgical drain. The sheaths can be used with thesurgical drains of the subject invention, and they can also be used withother cylindrical structures such as surgical drains, tubes, catheters,cannulas, and the like. As with the subject surgical drains, the subjectsheaths can be used in percutaneous, minimally invasive surgical, opensurgical, or other interventional procedures.

Embodiments of the sheaths for surgical drains include a tubularstructure with a proximal and a distal end, and a lumen. The tubularstructure is configured to be disposed around a cylindrical structure,such as a surgical drain. By “cylindrical structure” is meant acatheter, cannula, tube, drain, etc. which has a cylindrical shape. Inthe discussion below, both the terms “tubular structure” and “sheath”will be used to refer to the sheath of the subject invention. By“disposed around” a cylindrical structure is meant that the tubularstructure is configured to substantially surround the outer surface of acylindrical structure, and is dimensioned such that is has sufficientlength and diameter to surround the outer surface of the cylindricalstructure. The tubular structure can be dimensioned to fit around asurgical drain without a significant gap between the surgical drain andthe sheath, such that the sheath is closely applied to the outer surfaceof the surgical drain.

The tubular structure includes a distal end configured to be placed in abody cavity, such as a thoracic body cavity, and change in diameter whenpresent in the body cavity from a first diameter to a second diameterthat is smaller than the first diameter. The change in diameter of thedistal end of the tubular structure is mediated by a diameter-varyingelement, described further below. The proximal end of the tubularstructure is configured to be outside of the body when the distal end ispresent in the body cavity.

The tubular structure of the subject invention is therefore an elementthat can be disposed around a surgical drain, tube, cannula, etc., whichhas been placed in a body cavity. The tubular structure can thereforeinclude an elongated structure. The body cavity can include, but is notlimited to, any body cavity in need of draining, such as a thoracic bodycavity, which includes a body cavity in the chest including a pleuralbody cavity, an abdominal body cavity, a gastrointestinal body cavity, apelvic body cavity, a genitourinary body cavity, a cavity in the brainor spinal cord, a cavity in an extremity such as an arm or leg, etc.Further, the body cavity can be an anatomical or “natural” body cavity,e.g., the pleural space, or it can be a surgically-created ordisease-created body cavity, e.g., an abscess cavity. As such, thedimensions of the tubular structure will vary depending on thedimensions of the surgical drain that it is used with. For example, asheath configured to be disposed around an abdominal surgical drain canbe longer than a surgical drain configured to drain a urinary bladder.Similarly, a tubular structure configured to surround a larger abdominalbody cavity drain can have a larger diameter than a tubular structureconfigured to surround a smaller urinary bladder drain. Therefore, thelength of the tubular structure is generally longer than that of theassociated surgical drain, and may range from less than 1 cm to morethan 400 cm, such as from 20 cm to 150 cm, and including from 20 cm to40 cm.

The lumen in the tubular structure is dimensioned to fit around asurgical drain without a significant gap between the surgical drain andthe sheath, such that the sheath is closely applied to the outer surfaceof the surgical drain. As such, the inner diameter of the lumen willvary depending on the size of the surgical drain. Therefore, the innerdiameter of the tubular structure may range from less than 1 mm to morethan 5 cm, such as from 3 mm to 2 cm, and including from 5 mm to 10 mm.

The sheath can be made of any suitable biocompatible materials with alow coefficient of friction such as polymers including but not limitedto polyvinylchloride, polyurethane, polyethylene, polypropylene,polyamides; polymers which can be degraded by electromagnetic radiation,or laser light, biodegradable materials, plastic, silicone, metals;metal alloys; and combinations thereof. The sheath can further have oneor more fenestrations to allow drainage.

The tubular structure has a distal end that is configured to be placedinto a body cavity. The tubular structure has a proximal end that isconfigured to be outside of the body when the distal end is present inthe body cavity.

The tubular structure can be placed around a surgical drain before thesurgical drain is placed in the body cavity. In some embodiments, thetubular structure which is disposed around a surgical drain may beconfigured to have a smaller diameter prior to insertion, and beconfigured to have a larger diameter when present in the body cavity. Inembodiments where the sheath is constructed of biodegradable materials,the sheath can provide cushioning for an indwelling drain, and collapseafter withdrawal of the enclosed drain. The sheath formed ofbiodegradable material simply stays painlessly collapsed within the bodyor alternatively remains in place until absorbed by the patient ratherthan be withdrawn.

The tubular structure in some embodiments can be secured to a surgicaldrain. In some embodiments, the proximal end of the tubular structure issecured to the proximal end of the elongated structure, and in someembodiments, the distal end of the tubular structure is secured to thedistal end of the elongated structure. In some embodiments, the tubularstructure can be secured to the surgical drain in more than onelocation, e.g., at both ends of the surgical drain.

By “secured” to a surgical drain is meant attaching the tubularstructure, or sheath, to a surgical drain using any suitable securingmeans, such as with a clip, a suture, simple surgical ligature, anadhesive, etc. In some embodiments, more than one method of securing canbe used. As discussed above, the tubular structure can be secured to anelongated structure of the subject invention, and the tubular structurecan also be secured to any suitable cylindrical structure such as anysurgical drain, tube, catheter, cannula, etc.

As discussed above, the sheaths of the subject invention can include adiameter-varying element, which is an element that can significantlychange the diameter of the subject sheath. In addition to the ability tochange the diameter of a surgical drain, the diameter-varying elementcan provide hoop strength. By hoop strength is meant the ability of adrain or tube to withstand pressure, bending or crushing forces. Thediameter-varying element can change the sheath of the subject inventionfrom a larger diameter, which is referred to as an “expanded” state, toa smaller diameter, which can be referred to as a “collapsed” state. By“significantly change the diameter” of the sheath of the subjectinvention is meant a change in diameter of at least 20%, such as atleast 30%, or at least 40%, or more than 50%, more than 70%, more than80%, more than 90%, or more than 99% etc. In some embodiments, thesignificant change in diameter can be a decrease in diameter, and insome embodiments, the significant change in diameter can be an increasein diameter.

The sheath may or may not include a diameter-varying element. Thediameter-varying element as present in a sheath can be a wire, or aballoon filled with a fluid, which embodiments are discussed furtherbelow. As such, the diameter-varying element is an element that can beinserted into or removed from a sheath (e.g., a wire), or it can be anelement that is altered when present in the sheath (e.g., a balloon thatis filled with a liquid). As such, the diameter-varying element can bepresent in a sheath when the sheath is placed in a body cavity, or thediameter-varying element can be placed into a sheath after the sheathhas been placed in a body cavity. The diameter-varying element, whenpresent, may or may not be integrated with the subject sheath. Byintegrated is meant that the diameter-varying element cannot beseparated from the tubular structure without irreparably altering thetubular structure.

For example, in some embodiments, the diameter-varying element is anelement that maintains the sheath in a larger diameter (e.g., apreformed wire), which decreases to a smaller diameter once thediameter-varying element is removed. In other embodiments, thediameter-varying element is an element that can change the diameter of asheath from a larger diameter to a smaller diameter (e.g., a straightwire inserted into preformed spiral tubing) once the diameter-varyingelement is inserted. In yet another embodiment, the diameter-varyingelement is altered when present in a sheath to decrease the diameter ofthe sheath before removal (e.g., a balloon that can have the airremoved).

In some embodiments, there can be more than one diameter-varying elementin a sheath, or more than one type of diameter-varying element insheath. In other embodiments, the tubular structure may be configured tohave a smaller diameter prior to insertion, and be configured to have alarger diameter when present in the body cavity.

The diameter-varying element has a length sufficient to extend at leastalong the portion of the sheath that is inside the body cavity, suchthat the diameter-varying element provides a segment of the distal endof the sheath which can significantly change in diameter when present inthe body cavity. For example, in certain embodiments, thediameter-varying element is present in the distal one third of a sheath.In some embodiments, the diameter-varying element is present in thedistal half of a sheath. In some embodiments, the diameter-varyingelement is present along the entire length of the sheath. Therefore, thelength of the diameter-varying element may range from less than 1 cm tomore than 400 cm, such as from 20 cm to 150 cm, and including from 20 cmto 40 cm.

The diameter-varying element as embodied in a sheath may be present inthe wall of the sheath. By “wall” of the sheath is meant the portion ofthe tubular structure which surrounds the surgical drain. In thisembodiment, the tubular structure can have one or more fenestrations inthe wall to allow for drainage of body fluids through the wall of thetubular structure. In other embodiments the “wall” can have a spiralconfiguration. In this embodiment, the “wall” of the tubular structureis more of a support, in that the “wall” is not a continuous wall, butrather is a support structure which, once placed in a body cavity,allows “walls” to be formed by the body tissue which surround thestructure. For example, the “wall” of the tubular structure may beformed of tubing in a spiral configuration, which may have adiameter-varying element inside the tubing (e.g., a wire)

FIGS. 16A and 16B show an embodiment of a sheath 1655 according to theinvention. The sheath 1655 is configured such that any suitable surgicaldrain, tube, catheter or cannula can be inserted into the sheath (notshown). In FIG. 16A, the sheath in an expanded configuration is shown,e.g., with inflated balloons 1690 in the wall of the sheath. In FIG.16B, the sheath is shown in a collapsed configuration, in which thediameter-varying element, e.g., balloons, have been deflated byaspirating air, foam, liquid, etc. In this embodiment, thediameter-varying element is present along the entire length of thesheath, such that the entire diameter of the sheath is decreased.

In some embodiments of the invention, as with the surgical draindiscussed above, the sheath may further comprise branches. By “branches”or “limbs” is meant one or more extensions, or limbs, of the mainportion of the sheath that can be configured to be disposed around abranched surgical drain, such as a surgical drain of the subjectinvention. For example, in draining a body cavity in the chest, onebranch or limb of a surgical drain can be placed in the upper portion ofthe chest, and another branch of the surgical drain can be placed at thebase of the chest. A sheath configured to surround a surgical drain ofthe subject invention can therefore have two or more branches, or threeor more branches, or four or more branches, etc. The branches may, insome embodiments, have a diameter that is smaller than the diameter ofthe proximal portion of the sheath.

As summarized above, sheaths of the invention may include adiameter-varying element. FIGS. 17A and 17B show views of an embodimentof a sheath of the invention where the sheath includes adiameter-varying element in the form of a plurality of parallelballoons. FIG. 17A shows the expanded configuration of the sheath, withthe balloons 1790 inflated with sheath 1755 cushioning the effects ofthe drain (not shown). The balloons are inflated via one-way valve 1705and tubing 1704. Also shown is tubing 1712 for a drug delivery lumen,discussed further below. FIG. 17B illustrates the collapsed form of thesheath 1755, prior to withdrawal.

FIGS. 18A and 18B illustrate an embodiment of the sheath 1855, where thesheath includes a diameter-varying element in the form of balloons. FIG.18A shows a cross-sectional view of the sheath. FIG. 18B shows a cutawayview of this embodiment of the subject sheath, showing sheath 1855 withballoons 1890 and fenestrations 1832. In this embodiment, the balloons1890 are potential space, which can be filled by air, gas,self-inflating foam, etc., which allows for cushioning the tissues fromthe pain while surgical drain 1825 is indwelling. At time of withdrawalof the drain, the balloons 1890 in the sheath 1855 can be left inflatedor deflated depending on operator preference, as shown in FIGS. 20 and21 (described below). However, at the time of withdrawal of the sheath,the balloons can be deflated via application of suction to the balloonsthrough a one-way valve. Deflating the balloons will decrease theoverall diameter of the surgical drain and sheath combination, anddecrease the pain of withdrawal. Furthermore, deflation of the sheathcan increase the safety of the procedure for the patient, as the ingressof air during withdrawal is less likely through the deflated sheath. Inanother embodiment, the potential space of the balloons can be filled byself-inflating spongiform foam of various possible materials.

FIG. 19 illustrates another embodiment of the sheath, showing employmentof the sheath 1955 over a surgical drain 1925 which has been placed inthe thoracic cavity. The inflated balloon sheath 1955 allows the drain1925 to drain via the fenestrations 1932 in the sheath and thefenestrations 1930 in the drain itself.

In FIG. 20, the surgical drain is being withdrawn from the chest whilethe balloons in sheath 2055 are inflated. In this embodiment, inflationof the balloons in the sheath can cushion the tissues from the pain ofthe drain 2025 being withdrawn. Also shown in this figure arefenestrations 2032 in the sheath and fenestrations 2030 in the drain.

Alternatively, FIG. 21 shows withdrawal of the surgical drain in whichthe balloons of the sheath that surround the surgical drain 2125 havebeen deflated. In this embodiment, the deflation of the balloons in thesheath 2155 reduces the diameter of sheath, shown as element 2156, whichcan both decrease the pain of withdrawal and increase the safety of theprocedure. Ingress of air during withdrawal is less likely through adeflated sheath 2156.

As discussed above, the sheath can be secured to a surgical drain at theproximal end of the drain, or the distal end of the drain. FIG. 22illustrates the embodiment in which the operator has chosen to fix thesheath 2255 to the drain 2225 at the proximal end of the drain, or theend farthest from the patient. In this embodiment, the sheath is fixedto the surgical drain with a securing means 2265. The sheath can besecured to any suitable surgical drain, or can be attached to a surgicaldrain of the subject invention, using any suitable means.

FIG. 23 illustrates the drain 2325 slipping through sheath 2355 and outof the patient. The sheath in this embodiment is fixed at the proximalend with securing means 2365, and would therefore simply follow theremoval of the surgical drain. The sheath would be withdrawn in acollapsed state after the excess length of sheath 2355 relative to thedrain 2325 is exhausted. The collapsed sheath is smaller in diameter andhas no rigid structure of its own, which would minimize the pain andnarcotic medication requirement of the withdrawal process.

FIG. 24 illustrates another embodiment of a sheath 2455 where theoperator (e.g., a surgeon) chooses to fix the sheath to the indwellingsurgical drain 2425 at the distal end 2466 of the drain and sheath. Inthis embodiment, the sheath is also shown as being secured to thesurgical drain at the proximal end with securing means 2465.

FIG. 25 illustrates a similar embodiment to that shown in FIG. 24,illustrating how when the drain 2525 is withdrawn while the sheath issecured to the distal end of the drain, shown as element 2566, the drain2525 will slip through the sheath 2555 as it is initially withdrawn.Also shown is removal of proximal fixation element 2565. As the surgicaldrain is withdrawn further, the sheath will follow, which allows for thereduction of friction while the surgical drain and sheath are removed.Also shown are fenestrations in the surgical drain 2530, andfenestrations in the sheath 2532.

The sheath of the subject invention can also include a coating around asurface of the sheath. By “coating” is meant a substance that is appliedto a surface of a sheath. In some embodiments, the coating may be acoating that reduces friction, such as a friction-reduction coating, orit may be a coating that contains a pharmaceutical agent, e.g. an agentthat decreases the risk of blood clot formation, a coating thatdecreases the risk of infection, a coating that decreases pain, etc. Insome embodiments, the sheath may include a friction-reduction coating.Substances that may be used in a friction-reduction coating can includebut are not limited to: low friction polymers such as fluoro-ethyleneco-polymer (FEP), other low friction coatings that include paralyne,silicone, Teflon® coating, etc. The presence of a friction-reductioncoating on the outside of a sheath can decrease patient discomfort withremoval of the sheath. The presence of a friction-reduction coating onthe inside surface of a sheath can also improve the function of thesurgical drain, by decreasing the chances of a surgical drain becomingclogged by draining substances. A friction-reduction coating on theinside surface of a sheath could also the diameter of a surgical drainto be reduced while preserving the same capacity for drainage.

In some embodiments of the invention, the sheath includes, in additionto the lumen configured to be disposed around a surgical drain, anadditional lumen in the wall of the sheath configured to deliver asubstance into the body cavity. Substances that can be delivered intothe body cavity through an additional lumen can include pharmaceuticalagents such as antibiotics, anti-clotting agents, anesthetic agents,etc. Pharmaceutical agents can be administered while the sheath is inplace, for example, they can be administered continuously orintermittently for therapeutic treatment of infection, for example. Inother embodiments, pharmaceutical agents can be administered in a singledose, for example, if it is desired to administer an anesthetic agentalong the tract of the sheath prior to withdrawal of the sheath. In someembodiments, there can be more than one lumen. The lumen configured fordelivery of a therapeutic substance, such as a pharmaceutical agent, canhave a valve on the end, and can be attached to a syringe for deliveryof the agent. As with drains of the invention, e.g., as described above,this lumen may be in fluid communication with a source of the agent,such as in fluid communication with a source of the agent positioned atthe proximal end of the sheath.

FIG. 26 and FIG. 27 show an embodiment of the subject sheath that showsthe incorporation of tubing 2612 into the device. The tubing 2612 may bepresent throughout the entire length of the sheath 2655, or the tubingmay be present only in a portion of the device, e.g., in the proximalthird, or the proximal half of the sheath, etc. A cross-sectional viewof the sheath 2655 with the delivery lumen 2614 is shown in FIG. 27.Medications to treat disease may be given via tubing 2612. Fenestrations2632 present in the sheath 2655 that is employed over surgical drain2625 can allow for the dispersal of medications of therapeutic value tothe space in the body cavity that is drained by the device. Or the samedelivery system would aid in pain control by delivering topicalanesthetic medication during the period of drain use and or inpreparation for withdrawal.

Also of interest are sheaths that provide cushioning for a surgicaldrain, tube, cannula, catheter etc. Embodiments of a cushioning sheathcan include a sheath where the wall of the sheath includes an inner andouter layer, and the space between is filled with a cushioning material.Cushioning material can include foam, such as a self-inflating foam, afluid such as air or liquid, etc., or any other suitable cushioningmaterial. In some embodiments, a cushioning sheath may have a wallformed of a single layer, however the wall can be constructed such thatthe wall is thick enough to provide cushioning for an enclosed drain. Insome embodiments, a sheath can have both a wall with inner and outerlayers thick enough to provide cushioning, and also have the spacebetween the inner and outer layers of the wall be filled with acushioning material, such as foam. The sheath as in this embodiment canbe constructed of any suitable biocompatible materials as disclosedabove. A sheath of this embodiment may or may not have one or morefenestrations to allow drainage. A cushioning sheath of this embodimentmay not have a separate diameter-varying element, however may passivelycollapse or decrease in diameter upon removal of the encased surgicaldrain or tube.

Methods of Using a Sheath

Methods of draining a substance from a body cavity can include methodsof using the subject sheaths with surgical drains to drain a substancefrom a body cavity. The sheath of the subject invention can be placedaround a cylindrical structure including a surgical drain such as thosedisclosed in the present application, or the sheath can be placed aroundany suitable surgical drain, tube, catheter, or cannula. The methods ofusing the subject sheaths can also include manufacturing a subjectsheath such that it is disposed around any surgical drain, which caninclude a surgical drain of the subject invention. The methods can alsoinclude positioning a surgical drain in a body cavity, where thesurgical drain has been manufactured as above to include a sheath of thesubject invention. Methods can also include placing a subject sheatharound a surgical drain prior to positioning the surgical drain in abody cavity.

The subject sheaths can be manufactured such that the sheath is disposedaround a surgical drain. In some embodiments, the sheath is not securedto a surgical drain. In other embodiments, the sheath can further besecured to the surgical drain (e.g., at the proximal end, or at thedistal end) at the time of manufacture. In some embodiments, the sheathcan be secured at more than one location, e.g., at the proximal end andthe distal end. In some embodiments, the surgical drain that is used canbe a surgical drain of the subject invention.

The methods can also include the positioning of a surgical drain in abody cavity, where the surgical drain has been manufactured as disclosedabove to include a sheath of the subject invention. As such, the methodcan include positioning the combination surgical drain and sheath in abody cavity simultaneously. In some embodiments, the surgical drain canbe a surgical drain of the subject invention.

Methods can also include placing a subject sheath around a surgicaldrain prior to positioning the surgical drain in a body cavity. As such,the methods can include placing a tubular structure around the outersurface of an elongated structure, and then positioning the distal endof the elongated structure and the tubular structure in a body cavity.For example, a subject sheath may be provided in a kit, which can alsoinclude a surgical drain. In this example, the method can includeplacing the sheath around the outer surface of a surgical drain, andpositioning the surgical drain in a body cavity (e.g., by a surgeon inan operating room). In some embodiments, the surgical drain can be asurgical drain of the subject invention.

The methods can also include securing the sheath to the surgical drain.As such, the methods can include securing the tubular structure asurgical drain, e.g., an elongated structure of the subject invention.The tubular structure can be secured to the elongated structure at thedistal end, such that the distal end of the tubular structure is securedto the distal end of the elongated structure. The tubular structure canalso be secured to the elongated structure at the proximal end, suchthat the proximal end of the tubular structure is secured to theproximal end of the elongated structure. The tubular structure can alsobe secured to a sheath in a location between the proximal and distalends, such as halfway between the proximal end and the distal end. Asdisclosed above, by “securing” is meant any suitable means for fixing orattaching a sheath to a surgical drain, such as by clipping, suturing,use of an adhesive, etc.

In embodiments in which a sheath has been secured to a surgical drain,the methods can include removing the sheath along with removing thesurgical drain. In embodiments where the sheath is secured to a surgicaldrain at the proximal or the distal end, both the sheath and thesurgical drain can be removed by pulling the surgical drain out of thebody cavity. In one embodiment, if the sheath is secured to the surgicaldrain at the distal end of the surgical drain, the surgical drain can beremoved, and as the distal end of the surgical drain is removed, theattached sheath will follow. Therefore, in embodiments in which thesurgical drain is an elongated structure of the subject invention, themethod can include removing a tubular structure secured to the distalend of the elongated structure, such that the tubular structure isremoved after the elongated structure has been removed.

In another embodiment, if the sheath is secured to the surgical drain atthe proximal end of the surgical drain, the surgical drain can beremoved, and as the proximal end of the surgical drain is removed, theattached sheath is removed along with the surgical drain. Therefore, inembodiments in which the surgical drain is an elongated structure of thesubject invention, the method can include removing a tubular structuresecured to the proximal end of an elongated structure, such that thetubular structure is removed at the same time as the elongated structureis removed.

The sheaths of the subject invention can be used with any suitabledrain, tube, catheter, cannula, or other cylindrical structure, etc.,used for any suitable purpose including but not limited to draining abody cavity, administering a pharmaceutical agent, perfusion, etc. Thesubject sheath, during use, can be maintained in the larger diameterwhile the distal end is present in the body cavity in order to providecushioning for an indwelling drain, tube, catheter, cannula, etc. Inaddition, the sheath can be maintained in the larger diameter while itis placed around the outer surface of a drain or tube in order to allowfor the largest diameter for the underlying drain or tube. Prior toremoval of the sheath, with or without the underlying drain or tube, thediameter of the distal end of the sheath can be decreased, which allowsfor easier removal of the sheath. Prior to insertion of the sheath, inembodiments in which the sheath is disposed around the outer surface ofa cylindrical structure such as a surgical drain, the sheath can bepresent in the smaller, or collapsed configuration, such that the sheathand surgical drain can be inserted through a smaller skin incision, forexample. In some embodiments, the diameter of the sheath can remain inthe expanded configuration during removal of the underlying drain ortube, in order to cushion the surrounding tissues during withdrawal ofthe underlying drain or tube.

As discussed above, the change in diameter of the distal end of thesheath may be mediated by a diameter-varying element. In someembodiments, the diameter-varying element is present in the wall portionof a sheath and is altered before the sheath is removed from the bodycavity. For example, in the case of a sheath in which thediameter-varying element includes one or more balloons filled with foamin the wall portion, the filled balloons in the wall result in anexpanded wall portion of the sheath, and therefore a larger diameter ofthe sheath. Once the foam or air within self-expanding foam is removedfrom the balloons, the sheath will decrease in size, thereby decreasingthe overall diameter of the sheath.

FIG. 29 is a schematic of percutaneous insertion of a sheath which hasbeen placed over a surgical drain. In this embodiment, the combinedsheath 2955 and surgical drain 2925 are being introduced into thepleural cavity using implements for percutaneous insertion, includingguidewire 2921 and introducer sheath 2922. In this embodiment,percutaneous insertion of the sheath and surgical drain can be performedusing any suitable technique, such as the Seldinger technique. Theguidewire is inserted through the needle after the local tract has beenanesthetized.

The anesthetized tract can then be dilated with dilators placed over aguidewire before inserting the small diameter introducer sheath 2922over the guidewire 2921. The sheath and surgical drain can be placedinto a body cavity while the sheath is in the collapsed, or unsupportedsmall diameter state, which allows for a smaller skin incision and asmaller tract through the tissue. After placement of the sheath andsurgical drain into the thoracic cavity, the sheath can be expanded tolarger diameter configuration (e.g., by inflating balloons in the wallof the sheath).

Use of the sheath while the surgical drain is indwelling can decreasethe discomfort associated with an indwelling drain. Furthermore, in someembodiments, when it is time to remove the drain, the diameter of thesheath can be decreased by mediating the diameter-varying element (e.g.,removing foam or liquid from a balloon, etc.). Once the sheath hasreached the small diameter configuration, the sheath and surgical draincan be removed.

The description of the present invention is provided herein in certaininstances with reference to a subject or patient. As used herein, theterms “subject” and “patient” refer to a living entity such as ananimal. In certain embodiments, the animals are “mammals” or“mammalian,” where these terms are used broadly to describe organismswhich are within the class mammalia, including the orders carnivore(e.g., dogs and cats), rodentia (e.g., mice, guinea pigs, and rats),lagomorpha (e.g., rabbits) and primates (e.g., humans, chimpanzees, andmonkeys). In certain embodiments, the subjects, e.g., patients, arehumans.

Systems

As summarized above, systems for draining a body cavity are alsoprovided. A system as in the subject invention can include a surgicaldrain configured to drain a body cavity (such as a surgical drain of theinvention), and/or a sheath of the invention (such as described above),and a drainage apparatus.

The surgical drain of the subject invention has a lumen which isconfigured to drain a substance from a body cavity. The surgical drainalso has a proximal end which is configured to be outside of the bodywhen the distal end of the surgical drain is present in the body.Therefore, the proximal end of the surgical drain can be attached to adrainage apparatus. By “drainage apparatus” is meant any device orchamber which can be attached to the proximal end of a surgical drain,that can be used to collect a substance drained from the body cavity,e.g., fluid, air, blood, etc. For example, the proximal end of thesurgical drain can be attached to any suitable drainage apparatus suchas a collection bag or container. The surgical drain can be configuredto drain by gravity. The drainage apparatus can also include a valve,such as a flutter valve, or a one-way valve, to prevent body fluids fromflowing back into the body, air from leaking in, and also to preventcontamination of the body cavity from the environment.

In some embodiments, when the surgical drain is used in a pleural bodycavity, the proximal end of the surgical drain may be attached to adrainage apparatus which includes a “water seal” chamber which acts as aone-way valve.

The presence of a water seal allows air and/or fluid to escape from thepleural space, maintains the slightly negative pressure in the pleuralspace, and prevents any contamination from outside the patient's body.In some embodiments, such as with a surgical drain in the pleuralcavity, the proximal end of the surgical drain can be attached to asuction device.

Kits

Also provided are kits that at least include the subject devices. Thesubject kits at least include a surgical drain or a sheath of thesubject invention and instructions for how to use the device in aprocedure.

In some embodiments, the kits can include at least one surgical drain.In other embodiments, a set can also include a sheath configured to bedisposed around the surgical drain, and instructions for placing thesheath around either a surgical drain of the subject invention, oranother suitable sheath. The kits can also include one or more securingdevices for attaching a sheath to a surgical drain, such as a clip, aneedle and suture, an adhesive, etc. In another embodiment, a drain thatmay or may not have a sheath attached may be provided with items neededfor introducing a surgical drain into a body cavity (e.g., a drainintroducer kit) using percutaneous or minimally invasive methods. Adrain introducer kit can include implements suitable for inserting asurgical drain or surgical drain and attached sheath into a body cavity,such as an introducer needle, an introducer cannula, a dilator, aguidewire, etc.

In some embodiments, the kits can also include a drainage apparatus,such as a collection bag or container, a valve configured to be attachedto the proximal end of the surgical drain, a suction apparatus, etc.

The instructions for using the devices as discussed above are generallyrecorded on a suitable recording medium. For example, the instructionsmay be printed on a substrate, such as paper or plastic, etc. As such,the instructions may be present in the kits as a package insert, in thelabeling of the container of the kit or components thereof (i.e.associated with the packaging or subpackaging) etc. In otherembodiments, the instructions are present as an electronic storage datafile present on a suitable computer readable storage medium, e.g.,CD-ROM, diskette, etc. The instructions may take any form, includingcomplete instructions for how to use the device or as a website addresswith which instructions posted on the world wide web may be accessed.

Utility

The present invention describes surgical drains and sheaths that can beused for drainage of body cavities, spaces or organs that functions as atypical surgical drain, tube or cannula, which has the capability ofcollapsing to a state of reduced diameter. The subject surgical drainscan be placed intraoperatively during open procedures or viapercutaneous placement via nonguided techniques or guided techniquessuch as (but not limited to) x-rays, fiberoptic, endoscopic,ultrasonographic or other imaging techniques like magnetic resonanceimaging. The device achieves these ends by providing for a significantdecrease in drain diameter prior to withdrawal of the device. Access toany body space or organ for various purposes including, but not limitedto perfusion, treatment or drainage is possible and where withdrawal ofa device with a reduction in diameter is beneficial.

Incorporation of a diameter-varying element mechanism as a part of theinvention provides as well for insertion of the drain in a collapsed ornon-collapsed state, depending on the preference of the operator. Thefunctioning diameter of the drain can be maintained at a relativelylarge diameter while the function of the tube (e.g., drainage,perfusion, drug delivery, etc.) The larger functioning diameter ischangeable to a smaller diameter for insertion and withdrawal of thedrain. The variable diameter is based on the concept of removing thesupporting air, gas, liquid, or solid and allowing the reduction ofdiameter or collapse of the tube or drain prior to insertion orwithdrawal. The varying diameter element permits several advantagesincluding but not limited to easier insertion of the drain, easier, lesspainful withdrawal of the drain, improved surface area of functioningtubing providing drainage, multiple limbs exiting through a single mainlimb, and drug delivery along the tissue tract.

The collapsible nature of the invention permits several other functionsincluding the use of softer materials which are less likely to injuretissues. Safety is also improved by the collapse of the drain, whichdecreases the opportunity for iatrogenic introduction of outside airduring withdrawal.

In addition to the ability to vary the diameter of the device, thesubject surgical drains can also have branches, allowing for widerdraining through a single skin incision or opening, without the need forplacement of multiple drains. For example, after cardiothoracic surgery,separate drains are often placed into one or both pleural cavities andone or more tubes are often concomitantly placed into the mediastinum orpericardial space. Therefore, patients often experience the discomfortof 3 or 4 indwelling tubes or drains in the chest cavity. Thisdiscomfort is then increased by the pain, often despite narcoticadministration, of the removal of the multiple drains. For manypatients, removal of the tubes is the most painful part of the operativeexperience and recovery.

The surgical drain can also allow in one embodiment the delivery of painmedication or other desired medication via a drug delivery lumen.Furthermore, by using branches or limbs constructed with malleabletubing or wire, the device permits directivity or malleability of theinvention away from delicate structures, yet later when collapsed theinvention is withdrawn safely. The invention facilitates wide saferdrainage, yet limits the number of skin penetrations, pain, discomfortand scarring while achieving this goal.

The present invention also describes sheaths that can be used with asurgical drain, tube, catheter, or cannula, or other cylindricalstructure. The sheath can provide some cushioning effect for anyindwelling drain or cannula while it is in place. Also, the sheath canalso allow in one embodiment the delivery of pain medication or otherdesired medication via a drug delivery lumen. Drugs could beadministered while the sheath is in place, or they can be used inpreparation for the imminent withdrawal procedure. During the actualwithdrawal the invention provides a gliding surface for the drain toexit the body and then follows in the collapsed state directly or ifattached by the operator to the distal end the invention inverts thusreducing further the friction and pain.

The unique nature of the collapsing drain, tube or cannula enables otherfeatures such as ease of insertion of a larger functioning diameter tubein awake patients, multiple drainage branches, adjustable placement ofthe branches and centralization of the branches into a single drainagelumen exiting the body. The invention facilitates wide safer drainage,yet limits the number of skin penetrations, pain, discomfort andscarring while achieving this goal.

The present invention describes a sheath for shielding the patient oranimal from an indwelling drain, tube, catheter, or cannula. The sheathcan decrease the pain associated with the placement or withdrawal ofsurgical drains or other transcutaneous indwelling catheters, tubes orcannulas. The device can also be used with any drains, catheters, tubes,cannula or other cylindrical structures that are inserted into bodyorifices or tracts. The device acts as a sheath to shield the encloseddrain, catheter, tube or cannula from direct contact with painful nerveendings while the drain, catheter tube or cannula is in place and/or asit is withdrawn. The sheath can allow the full function of the enclosedfunctioning tube via fenestrations, which allows the device to function.The sheath may also have incorporated in the wall of the sheath anothertube or catheter for the administration of medication to treat apathologic process in the proximity of the device or topharmacologically decrease the pain of the drain, catheter tube orcannula while indwelling and or upon removal. In some instances, thesubject sheath can be secured at the time of manufacture to the proximalend or distal end of the enclosed drain, catheter, tube or cannula. Insome embodiments, the subject sheath can be placed at the time ofmanufacture around an enclosed drain, catheter, tube or cannula, withoutbeing secured to the enclosed drain, catheter, tube or cannula. Thesubject sheath can also be fixed by the operator (e.g., a surgeon) tothe proximal end or distal end of the enclosed drain, catheter, tube orcannula, and then in collapsed form the sheath can be removed from thebody attached to the previously enclosed drain, catheter, tube orcannula. The sheath may exit directly with the attached drain orcatheter, or by inverting, depending upon the method of attachment tothe enclosed drain, catheter, tube or cannula.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims. It is also to be understood that theterminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only by the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

1. A surgical drain comprising: an elongated structure comprising adistal end configured to be placed in a body cavity and change indiameter when present in the body cavity from a first diameter to asecond diameter that is smaller than the first diameter, wherein thechange in diameter is mediated by a diameter-varying element; a proximalend configured to be outside of the body when the distal end is presentin the body cavity; a lumen configured to drain a substance from thebody cavity; and a syringe attached to the lumen.
 2. The surgical drainaccording to claim 2, further comprising a diameter-varying element. 3.The surgical drain according to claim 2, wherein the diameter-varyingelement is present when the elongated structure is initially placed inthe body cavity.
 4. The surgical drain according to claim 2, wherein thediameter-varying element is inserted into the elongated structure afterthe elongated structure has been placed in the body cavity.
 5. Thesurgical drain according to claim 2, wherein the elongated structurefurther comprises a wall portion and a core portion.
 6. The surgicaldrain according to claim 5, wherein the diameter-varying element is inthe wall portion of the elongated structure.
 7. The surgical drainaccording to claim 5, wherein the diameter-varying element is in thecore portion of the elongated structure.
 8. The surgical drain accordingto claim 2, wherein the diameter-varying element is a wire.
 9. Thesurgical drain according to claim 2, wherein the diameter-varyingelement is a balloon.
 10. The surgical drain according to claim 9,wherein the balloon has a spiral configuration.
 11. The surgical drainaccording to claim 9, wherein the balloon has a linear configuration.12. The surgical drain according to claim 7, wherein thediameter-varying element is a central spline.
 13. The surgical drainaccording to claim 1, wherein the elongated structure further comprisesa tubular structure disposed on the outer surface of the elongatedstructure.
 14. The surgical drain according to claim 15, wherein thetubular structure is secured at the distal end of the elongatedstructure.
 15. The surgical drain according to claim 15, wherein thetubular structure is secured at the proximal end of the elongatedstructure.
 16. The surgical drain according to claim 1, wherein theelongated structure further comprises branches.
 17. The surgical drainaccording to claim 1, wherein the elongated structure further comprisesa coating.
 18. The surgical drain according to claim 17, wherein thecoating is a friction-reduction coating.
 19. The surgical drainaccording to claim 5, wherein the elongated structure further comprisesa lumen in the wall of the elongated structure configured to deliver apharmaceutical agent.
 20. A system comprising: an elongated structurecomprising: a distal end configured to be placed in an body cavity andchange in diameter when present in the body cavity from a first diameterto a second diameter that is smaller than the first diameter, whereinthe change in diameter is mediated by a diameter-varying element; aproximal end configured to be outside of the body when the distal end ispresent in the body cavity; a lumen configured to drain a substance fromthe body cavity; a syringe attached to the lumen; and a drainageapparatus.
 21. The system according to claim 20, further comprising adiameter-varying element.
 22. A method of draining a body cavity in abody, the method comprising: positioning a distal end of an elongatedstructure in a body cavity, wherein the elongated structure comprises: adistal end configured to be placed in a body cavity and change indiameter when present in the body cavity from a first diameter to asecond diameter that is smaller than the first diameter, wherein thechange in diameter is mediated by a diameter-varying element; a proximalend configured to be outside of the body when the distal end is presentin the body cavity; and a lumen configured to drain a substance from thebody cavity; draining a substance from the body cavity via thepositioned surgical drain; decreasing the diameter of the distal end ofthe elongated structure prior to removal of the elongated structure; andremoving the distal end of the elongated structure from the body cavity,wherein the body cavity is an abdominal body cavity or a cavity in anextremity of the body. 23.-29. (canceled)
 30. The method according toclaim 22, wherein the method further comprises removing a tubularstructure disposed around the outer surface of the elongated structure,wherein the tubular structure is secured to the distal end of theelongated structure, such that the tubular structure is removed afterthe elongated structure has been removed.
 31. The method according toclaim 22, wherein the method further comprises removing a tubularstructure disposed around the outer surface of the elongated structure,wherein the tubular structure is secured to the proximal end of theelongated structure, such that the tubular structure is removed at thesame time as the elongated structure is removed. 32.-48. (canceled)